The PowerPort® Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anticancer medicines (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

When used with a Powerloc® safety infusion set, the PowerPort® device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.

Device Description

PowerPort® Implantable Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. Implantable Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Catheters, included with the port, are pre-attached or may be attached to the port by the physician during implantation.

PowerPort® Implantable Ports can be used for routine vascular access using a non-coring access needle. However, for power injection procedures, PowerPort® ports must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) to create a power-injectable system.

AI/ML Overview

The provided text describes specific acceptance criteria and the studies conducted to demonstrate that the Bard Power-Injectable Implantable Ports (PowerPorts®) meet these criteria, primarily focusing on the expansion of their indications for use to explicitly include anti-cancer medicines.

Here's an analysis of the acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance/Met?
Bench Performance Tests:
Stem-Catheter Air Leak Test	Met (Devices withstood and passed robust physical testing after chemical conditioning simulating chemotherapy infusions).
Stem-Catheter Air Burst Test	Met (Devices withstood and passed robust physical testing after chemical conditioning simulating chemotherapy infusions).
Stem-Catheter Tensile Strength Test	Met (Devices withstood and passed robust physical testing after chemical conditioning simulating chemotherapy infusions).
Multiple Power Injections Test	Met (Devices withstood and passed robust physical testing after chemical conditioning simulating chemotherapy infusions).
Port System Injection Rate Test	Met (Devices withstood and passed robust physical testing after chemical conditioning simulating chemotherapy infusions).
Clinical Equivalence (for expanded Indications for Use):
Support for use with anti-cancer medicines (chemotherapy)	Clinically supported by a comprehensive literature review (encompassing two randomized controlled trials, four prospective registries, and five retrospective analyses all using Bard® ports). Further reinforced by real-world evidence and two sponsored retrospective studies demonstrating primary use of ports for chemotherapy in oncology patients. The expanded indication does not impact intended use, nor raise new safety/efficacy questions, concluding substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document details performance testing (bench tests) and clinical analysis (literature review and retrospective studies).

Bench Tests (Test Set): The document does not specify an exact number of devices used for each individual bench test. It states "the devices underwent chemical conditioning" and "the testing also demonstrated that devices were able to further withstand and pass all of the robust physical testing." This implies a representative sample of each device type was used.
- Data Provenance: This is in-house laboratory testing at Bard Access Systems (C.R. Bard, Inc.). It is prospective in nature as it was designed and performed specifically for this submission.
Clinical Analysis (Test Set - Retrospective Studies):
- Study 1 (DiMatteo C, Nishimoto B, Thomas I. 2014): "multicenter, retrospective database review" to determine AE/malfunction rates.
  - Sample Size: "subjects consisted of adult males and females ≥21 years of age who had infusions through a Bard port or any PIV." No specific number is provided in this summary.
  - Data Provenance: Retrospective, multicenter study. The country of origin is not explicitly stated but generally sponsored studies by US companies often involve US data.
- Study 2 (McDonald M. 2017): "retrospective multicentered study to assess the complication rates of oncology patients accessed with peripheral intravenous lines versus implantable ports."
  - Sample Size: "Patient data was collected from five different clinical sites for patients who were at least 21 years of age, had a Bard® Groshong® Port Catheter, had completed cancer therapy, and had maintenance flushes." No specific number is provided in this summary.
  - Data Provenance: Retrospective, multicenter study from five different clinical sites. Country of origin not explicitly stated.
- Health Claims Data Analysis: "retrospective analysis of US health care claims data."
  - Sample Size: Not specified beyond "US health care claims data."
  - Data Provenance: Retrospective, US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Bench Tests: The "ground truth" for the bench tests is defined by established engineering and material science principles, as well as predefined acceptance criteria derived from FDA guidance documents ("FDA Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990" and "FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995") and in-house protocols. No external experts are mentioned for establishing the ground truth of these physical tests; it's based on objective measurement against specifications.
Clinical Analysis (Retrospective Studies and Literature Review):
- Literature Review: The ground truth comes from the published clinical literature itself, assessed by the "clinical analysis" team at Bard/C.R. Bard, Inc. The qualifications of these reviewers are not stated.
- Retrospective Studies: The ground truth for these studies would be derived from the patient medical records/databases used. This medical information is typically established by treating physicians and other healthcare professionals (e.g., nurses administering infusions, radiologists performing imaging, pathologists for cancer diagnoses). The number and specific qualifications of clinicians establishing these initial patient records are not provided, as these are secondary analyses of existing data.

4. Adjudication Method for the Test Set

Bench Tests: No adjudication method is described beyond successful completion of the tests against predetermined acceptance criteria.
Clinical Analysis (Retrospective Studies and Literature Review): No explicit adjudication method (e.g., 2+1, 3+1) is mentioned for the literature review or the retrospective data analysis. The studies are described as reviewing existing data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done & Effect Size

No MRMC comparative effectiveness study is mentioned for this submission. The submission is not for a diagnostic imaging AI device but for an implantable port. Thus, the concept of human readers improving with AI assistance is not applicable here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable as the device is an implantable port, not an algorithm or AI system. Its performance is evaluated through physical characteristics, ability to withstand power injection, and clinical utility for drug delivery.

7. The Type of Ground Truth Used

Bench Tests: Objective physical measurements and functional performance against engineering specifications and regulatory guidance.
Clinical Analysis (for expanded Indications):
- Literature Review: Published clinical evidence and scientific consensus from existing randomized controlled trials, prospective registries, and retrospective analyses.
- Retrospective Studies: Patient medical record data / health care claims data, which reflects real-world clinical outcomes and diagnoses from healthcare professionals.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device, not an AI or machine learning algorithm that requires a "training set." The development of the port itself relies on engineering design principles, material science, and manufacturing processes.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for a physical device like this implantable port.

Summary

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July 8, 2019

C.R. Bard, Inc. Jeff Peterson Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116

Re: K181446

Trade/Device Name: Bard Power-Injectable Implantable Ports (PowerPorts®) Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port And Catheter Regulatory Class: Class II Product Code: LJT Dated: June 5, 2019 Received: June 6, 2019

Dear Jeff Peterson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Nikhil Thakur Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Summary (21 CFR 807.92) Bard PowerPort® Implantable Ports K181446

Submitter Information:

Bard Access Systems (C.R. Bard, Inc.) 605 North 5600 West Salt Lake City, Utah 84116

Phone: 480-303-2738 Fax: 480-449-2546

Contact Person: Jeff Peterson Requlatory Affairs Specialist Date of Submission: July 3, 2019

Subject Device Name:

Name of Device:

PowerPort® ClearVUE® isp Implantable Port .
PowerPort® ClearVUE® Slim Implantable Port ●
PowerPort® isp M.R.I.® Implantable Port .
PowerPort® M.R.I.® Implantable Port
PowerPort® duo M.R.I® Implantable Port ●
PowerPort® isp Implantable Port
PowerPort® Slim Implantable Port
PowerPort® Implantable Port
PowerPort® VUE Implantable Port ●
PowerPort® Vue M.R.I.® Implantable Port ●
Vaccess CT Power-Injectable Port

LJT - Port & Catheter, Implanted, Subcutaneous, Intravascular

Subcutaneous, implanted intravascular

Vaccess CT Low-Profile Titanium Power-● Injectable Port
Implanted Infusion Port

infusion port and catheter

21 CFR §880.5965

Class 2

Common or Usual Name: Product Code:

Requlation Name:

Regulatory Class: Regulation Number:

Predicate Device:

Name of Device:

PowerPort® Implanted Titanium Port with 8 . Fr. Chronoflex® Polvurethane Catheter (K060812)
PowerPort® Implanted Polymeric Port with 8 ●

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Fr. Chronoflex® Catheter (K063377)

•	Titanium PowerPort® isp Implanted Portwith 8 Fr. Chronoflex® PolyurethaneCatheter (K072215)
•	Titanium PowerPort® isp Implanted Portwith 6 Fr. Chronoflex® PolyurethaneCatheter (K072549)
•	MRI PowerPort® Implanted Port with 9.6 FrSilicone Catheter (K073423)
•	PowerPort® Implanted Port with Groshong®Catheter (K081311)
•	PowerPort® duo M.R.I. ® Implanted Portwith 9.5 Fr. Dual Lumen Chronoflex®Polyurethane Catheter (K090512)
•	PowerPort® ClearVUE® Slim Implantable Portwith 8Fr. Polyurethane Catheter (K122899)
Common or UsualName:	Implanted Infusion Port
Product Code:	LJT - Port & Catheter, Implanted,Subcutaneous, Intravascular
Regulation Name:	Subcutaneous, implanted intravascularinfusion port and catheter
Regulatory Class:	Class 2
Regulation Number:	21 CFR §880.5965

Summary of Change:

The purpose of the bundled submission is to expand the indications for use for this family of ports. The Indications for Use statements are being expanded to include the clarifying statement "including anti-cancer medicines (chemotherapy)" as related to the infusion of medicines.

Device Descriptions:

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Indications for Use of Device:

Technological Comparison to Predicate Devices:

There have been no changes to the technological characteristics or design including the device's physical attributes or manufacturing specifications of the Bard Power-Injectable Implantable Ports; therefore, they are identical and substantially equivalent with respect to basic design and function of the predicate devices. Expanding the indications for use statement to include the clarifying statement "including anti-cancer medicines (chemotherapy)" as related to the infusion of medicines, does not impact the intended use, and does not raise any new questions regarding safety or efficacy. The subject devices and the predicate devices are identical in the following ways:

Same Intended Use .
Same Target Population ●
Same Technological Characteristics ●
Same Fundamental Scientific Technology ●
Same Operating Principle ●
Same Implant Design and Materials .
Same Applicator Design and Materials
Same Performance Specifications .
Same Packaging Materials and Configurations ●
. Same Sterility Assurance Level and Method of Sterilization

The subject devices and the predicate devices are different in the following manner only:

. Expanded Indications for Use
There are no other changes to subject devices, see Table below.

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Subject and Predicate Device Comparison

	Subject Devices	Predicate Devices
Legal Manufacturer	No change from predicates	Bard Access Systems, Inc.
510(k) Status	PowerPort® ClearVUE® ispImplantable Port	PowerPort® ImplantedPolymeric Port with 8 Fr.Chronoflex® Catheter(K063377)
	PowerPort® ClearVUE® SlimImplantable Port	PowerPort® ClearVUE® SlimImplantable Port with 8Fr.Polyurethane Catheter(K122899)
	PowerPort® isp M.R.I.®Implantable Port	MRI PowerPort® ImplantedPort with 9.6 Fr SiliconeCatheter (K073423)PowerPort® ImplantedPolymeric Port with 8 Fr.Chronoflex® Catheter(K063377)
	PowerPort® M.R.I.®Implantable Port	MRI PowerPort® ImplantedPort with 9.6 Fr SiliconeCatheter (K073423)PowerPort® ImplantedPolymeric Port with 8 Fr.Chronoflex® Catheter(K063377)
	PowerPort® duo M.R.I.®Implantable Port	PowerPort® duo M.R.I. ®Implanted Port with 9.5 Fr.Dual Lumen Chronoflex®Polyurethane Catheter(K090512)
	PowerPort® isp ImplantablePort	PowerPort® Implanted Portwith Groshong® Catheter(K081311)Titanium PowerPort® ispImplanted Port with 6 Fr.Chronoflex® PolyurethaneCatheter (K072549)Titanium PowerPort® isp
	Implanted Port with 8 Fr.Chronoflex® PolyurethaneCatheter (K072215)
PowerPort® Slim ImplantablePort	PowerPort® Implanted Portwith Groshong® Catheter(K081311)Titanium PowerPort® ispImplanted Port with 6 Fr.Chronoflex® PolyurethaneCatheter (K072549)Titanium PowerPort® ispImplanted Port with 8 Fr.Chronoflex® PolyurethaneCatheter (K072215)
PowerPort® Implantable Port	PowerPort® Implanted Portwith Groshong® Catheter(K081311)MRI PowerPort® ImplantedPort with 9.6 Fr SiliconeCatheter (K073423)PowerPort® ImplantedTitanium Port with 8 Fr.Chronoflex® PolyurethaneCatheter (K060812)
PowerPort® VUE ImplantablePort	Titanium PowerPort® ispImplanted Port with 6 Fr.Chronoflex® PolyurethaneCatheter (K072549)
PowerPort® Vue M.R.I.®Implantable Port	PowerPort® ImplantedPolymeric Port with 8 Fr.Chronoflex® Catheter(K063377)
Vaccess CT Power-InjectablePort	PowerPort® ImplantedPolymeric Port with 8 Fr.Chronoflex® Catheter(K063377)Titanium PowerPort® ispImplanted Port with 6 Fr.
		Chronoflex® PolyurethaneCatheter (K072549)
	Vaccess CT Low-ProfileTitanium Power-InjectablePort	Titanium PowerPort® ispImplanted Port with 6 Fr.Chronoflex® PolyurethaneCatheter (K072549)Titanium PowerPort® ispImplanted Port with 8 Fr.Chronoflex® PolyurethaneCatheter (K072215)
	Intended Use	No change from predicates
	Indications for Use	The PowerPort® ImplantablePort is indicated for patienttherapies requiring repeatedaccess to the vascularsystem. The port system canbe used for infusion ofmedications including anti-cancer medicines(chemotherapy), I.V. fluids,parenteral nutrition solutions,blood products, and for thewithdrawal of blood samples.When used with a PowerLoc®Brand Safety Infusion Set, thePowerPort® device is indicatedfor power injection of contrastmedia. For power injection ofcontrast media, the maximumrecommended infusion rate is5 mL/s.
		K063377:The PowerPort® ImplantedPort is indicated for patientvascular therapies requiringrepeated access to vascularthe system. The port systemcan be used for infusion ofmedications, I.V. fluids,parenteral nutrition solutions,blood products, and for thewithdrawal of blood samplesWhen used with the PowerLocSafety Infusion Set, thePowerPort" device is indicatedfor power injection of contrastmedia. For power injection ofcontrast media, the maximumrecommended infusion rate is5 ml/s.
	K060812, K072215, K072549,K073423, K090512, K081311:The PowerPort® implantedport is indicated for patienttherapies requiring repeatedaccess to the vascularsystem. The port system canbe used for infusion ofmedication, I.V. fluids,parenteral nutrition solutions,blood products, and for thewithdrawal of blood samples.When used with aPowerLocTM safety infusionset, the PowerPortTM deviceis indicated for power injectionof contrast media. For powerinjection of contrast media,the maximum recommendedinfusion rate is 5 ml/s.
	K122899:The PowerPort® ClearVUE®Slim Implantable Port with 8FPolyurethane Catheter isindicated for patient therapiesrequiring repeated access tothe vascular system. The portsystem can be used forinfusion of medications, I.V.fluids, parenteral nutritionsolutions, blood products, andfor the withdrawal of bloodsamples.When used with a PowerlocⓇSafety Infusion Set (SIS), thePowerPort® device isindicated for power injection ofcontrast media. For powerinjection of contrast media
		infusion rate is 5 ml/s.
TechnologicalCharacteristics	No change from predicates	Ports are implantedsubcutaneously for long-termrepeatable vascular access.PowerPorts® are unique inthat they can also be powerinjected with contract mediafor CT imaging.
Features	No change from predicates	Port Body (including a self-sealing silicone septum),Radiopaque Catheter,CathLock
Materials	No change from predicates	Various Materials
Principles of Operation	No change from predicates	Implantable access devicedesigned to provide repeatedaccess to the vascularsystem.
Sterilization	No change from predicates	Sterilized to a minimum SALlevel of 1 x 10-6
Shelf Life	No change from predicates	Shelf life for these deviceswas established by evaluatingthe physical performance ofthe ports and catheters withtest components eitheraccelerated aged or real timeaged to 2 years.
Packaging	No change from predicates	These devices are packagedin three kit configurations:Basic, Intermediate, andMicrointroducer.

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Note: Device Indications for Use in Bold indicates a difference between the subject devices and predicate device.

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The subject device labeling has been revised/updated to include the expanded Indications for Use language regarding a clarifying statement of "including anti-cancer medicines (chemotherapy)" as related to the infusion of medicines.

Performance Data:

Verification and validation activities were designed and performed in accordance with Design Controls as per 21 CFR §820.30. The following guidance documents in conjunction with inhouse protocols were used to determine appropriate methods for evaluating the performance of the device:

. FDA Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990
FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995

Based upon the evaluation of the methods provided in the quidance, the following verification tests were conducted as Performance Testing - Bench:

Stem-Catheter Air Leak Test ●
. Stem-Catheter Air Burst Test
Stem-Catheter Tensile Strength Test ●
. Multiple Power Injections Test
. Port System Injection Rate Test

During performance testing, the devices underwent chemical conditioning which consisted of exposing the port, catheter, and CathLock junctions to chemicals simulating those used during chemotherapy infusions in the clinical environment. The testing also demonstrated that devices were able to further withstand and pass all of the robust physical testing sited above and have met all of the essential requirements identified.

The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device.

Clinical Analysis:

The expanded indications for use to include clarifying statement "including anti-cancer medicines (chemotherapy)" as related to the infusion of medicines is clinically supported by a comprehensive literature review. The review assessed relevant clinical literature related to the use of ports for the administration of chemotherapy medications for patients with cancer diagnoses. To further reinforce the use of ports for administering chemotherapy medications, Bard analyzed real-world evidence and sponsored retrospective studies. This data, summarized below, demonstrates the use of ports for administering chemotherapy medications for patients diagnosed with cancer.

A comprehensive literature review was conducted to collect and assess relevant clinical literature documenting the use of totally implantable ports for chemotherapy infusion in cancer patients. The literature reviewed encompassed two randomized controlled trials, four

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prospective registries, and five retrospective analyses. Bard® ports were used in all reviewed studies and showed the widespread use of implanted ports for chemotherapy.

A retrospective analysis of US health care claims data was conducted to assess the diagnosis codes related to procedures for the insertion of tunneled centrally inserted venous access devices with subcutaneous ports. The results revealed that 92% of procedures were related to a type of Cancer.

Two separate retrospective studies12 demonstrated that ports are primarily used for the administration of chemotherapy for oncology patients with cancer diagnoses. Please see the summaries below:

One study1 was a multicenter, retrospective data review to evaluate the maintenance flushing interval for patients using the Groshong® Distal Valved Port Catheter from C. R. Bard. Patient data was collected from five different clinical sites for patients who were at least 21 years of age, had a Bard® Groshong® Port Catheter, had completed cancer therapy, and had maintenance flushes with heparin/heparinized saline or normal saline.

The second study2 was a multicenter, retrospective database review to determine the adverse event (AE)/malfunction rates of ports and PIVs in subjects undergoing chemotherapy infusions. The purpose of the study was to collect data on subjects receiving chemotherapy to determine complication rates with ports and PIVs. Study subjects consisted of adult males and females ≥21 years of age who had infusions through a Bard port or any PIV.

These studies are included solely to demonstrate that ports are primarily used for the administration of chemotherapy (chemotherapy infusions) for oncology patients with cancer diagnoses.

Summary of Substantial Equivalence:

Based on the indications for use, technological characteristics, and additional performance testing, the Bard Power-Injectable Implantable Ports (PowerPorts®) meet the requirements that are considered sufficient for their intended use, and are substantially equivalent in design, materials, sterilization, and principles of operation to the legally marketed predicate devices cited.

References

1 McDonald M. Veins For Life Study: A retrospective multicentered study to assess the complication rates of oncology patients accessed with peripheral intravenous lines versu implantable ports for chemotherapy administration. 2017. Funded by C.R. Bard, Inc.

2 DiMatteo C, Nishimoto B, Thomas I. Distal Study: A retrospective study to extend the maximum maintenance flushing interval for ports with distally valved catheters. 2014. Funded by C.R. Bard, Inc.

Regulation Number and Section

§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.

(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.